Study of Personalized Immunotherapy in Adults With Metast... | NCT03189030

Studies
Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

NCT03189030

Sponsor

Aduro Biotech, Inc.

Status

Terminated

Last Update Posted

Oct 1, 2020Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Colorectal Neoplasms

Interventions

pLADD

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to business realignment

Expanded Access Info

Start Date

May 2, 2017Actual

Primary Completion Date

Oct 15, 2019Actual

Completion Date

Sep 2, 2020Actual

First Submitted Date

Jun 14, 2017

First Submission Date that Met QC Criteria

Jun 15, 2017

First Posted Date

Jun 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2020

Last Update Posted Date

Oct 1, 2020Actual

Name	Class
Hanlee P. Ji, MD	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.

Detailed Description

This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	pLADD treatment cycle is once every 3 weeks; starting dose 1×10^8 colony-forming units (CFU) administered IV over 1 hour, and if tolerated increasing to 1×10^9 CFU	Biological: pLADD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pLADD	Biological	via IV infusion	Treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0	Through study completion, an average of 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
able to provide adequate tumor tissue from at least 1 accessible tumor site
completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening
on maintenance standard-of-care chemotherapies or on treatment holiday
Eastern Cooperative Oncology Group (ECOG) 0 or 1
adequate organ function
progression of disease at the time of Enrollment

Exclusion Criteria:

BRAF V600E mutation
known allergy to both penicillin and sulfa drugs
implanted devices that cannot be easily removed
immunodeficiency, immune compromised state or receiving immunosuppressive therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010	United States
University of California Los Angeles

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided